MAUDE Adverse Event Report: ARTHROCARE CORPORATION 2.8MM Q-FIX ALL SUTURE ANCHOR; SUTURE UNITS

Catalog Number 25-2800

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2014

Event Type  malfunction  

Event Description

It was reported that during a shoulder procedure using a 2.8mm q-fix all suture anchor, upon tightening the sutures after insertion, the anchor pulled out of the bone.This happened a second time with an additional identical anchor.The surgeon opted to complete the procedure using a competitive device.There were no significant delays or patient complications reported as a result of this event.

• Brand Name: 2.8MM Q-FIX ALL SUTURE ANCHOR
• Type of Device: SUTURE UNITS
• Manufacturer (Section D): ARTHROCARE CORPORATION; austin TX
• Manufacturer (Section G): ARTHROCARE COSTA RICA; la aurora, heredia ; CS
• Manufacturer Contact: wendy laird ; 7000 w william cannon dr. bldg1; austin, TX 78735 ; 5123585933
• MDR Report Key: 3865194
• MDR Text Key: 4510700
• Report Number: 3006524618-2014-00051
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Catalogue Number: 25-2800
• Device Lot Number: 1045527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2014
• Initial Date FDA Received: 02/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR